This course is designed to provide participants with an understanding of the impact that ISO 14971:2007 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485:2003.
The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations. Particular focus is on the changes to the 2007 version and how the changes impact the risk management process.
Learning Objectives:
- Identify the links between ISO 13485 (QMS) and ISO 14971 (RM)
- Explain how risk management relates to the product lifecycle
- Define risk management terminology
- Outline the stages of the risk management process
- Define the key deliverables of the risk management process
Who Should Attend:
- Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel
- Decision makers on management system strategy
- Internal Auditors
Duration:
1 Day
Prerequisite:
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485:2003.
This course can be delivered as in-company training, customized for specific organizations and their circumstances.
